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Regulatory Focus™ > News Articles > 2020 > 9 > Recon: China vaccinates 100K for COVID; EUA for Roche COVID-flu combo test

Recon: China vaccinates 100K for COVID; EUA for Roche COVID-flu combo test

Posted 08 September 2020 | By Kari Oakes 

Recon: China vaccinates 100K for COVID; EUA for Roche COVID-flu combo test

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Genentech scores sixth FDA approval in lung cancer with Gavreto (Pharmafile)
  • US FDA Personnel Costs Drop: Is the Next Generation Taking Over? (Pink Sheet)
  • Gottlieb: Staged Access To Coronavirus Vaccine Possible Through EUA (Pink Sheet)
  • Why Saving The Economy Or Tackling The Pandemic Is A False Dilemma (Forbes)
  • Here’s how Trump could bigfoot the FDA and get a vaccine out ahead of the science (WKTV/CNN)
  • FDA Rejects Oleandrin, Extract Pushed By MyPillow CEO, As A Dietary Supplement (Forbes)
 
In Focus: International
  • Chinese drug firm says thousands have been vaccinated for COVID-19 on an emergency use scheme (Pharmafile) (Pink Sheet)
  • President of Sanofi France expects COVID-19 vaccine to be priced below ten Euros (Pharmafile)
  • NICE no for Pierre Fabre's Braftovi (PharmaTimes)
  • EU expands scope of Imbruvica to include untreated CLL patients (PharmaTimes)
  • Same Price & Trial Data: Scotland OKs Spravato Funding After England Says No (Pink Sheet)
  • WHO says India in talks to join 'COVAX' global vaccine scheme (Economic Times)
  • Australia announces deal for 84 million COVID-19 vaccine doses (BioPharma Reporter)
Coronavirus Pandemic
  • Senate to vote on scaled-down coronavirus relief package (The Hill)
  • WHO warns against 'politically motivated' information in coronavirus response (The Hill)
  • Pfizer CEO says people who don’t get vaccinated will become ‘weak link’ that allows coronavirus to spread (CNBC)
  • Merck CEO Stresses Need For ‘Fair Return’ On COVID-19 Interventions (Scrip)
  • Celltrion to begin mass producing antibody treatment before getting approval (Endpoints) (Reuters)
  • Trump and Biden accuse each other of politicizing Covid-19 vaccine (Financial Times)
  • Sinovac’s COVID-19 vaccine appears safe in older adults (PMLive)
  • Progress on BioNTech and Pfizer’s COVID-19 vaccine candidate BNT162b2 (PharmaLetter)
  • World must be better prepared for next pandemic, WHO says (CNBC)
  • India surpasses Brazil, second behind U.S., in total coronavirus cases (NBC) (NPR)
  • How Can You Tell If A COVID-19 Vaccine Is Working? (NPR)
  • Inovio partners with Thermo Fisher to bolster COVID-19 vaccine supply (Reuters)
Pharma & Biotech
  • Finance Watch: One Small Pain Drug Maker And Three Biotech SPACs Launch IPOs (Scrip)
  • Takeda to sell another non-core portfolio for $260 million to Cheplapharm (Pharmafile)
  • Extension study reveals Dupixent's benefit can last up to three years in moderate-to-severe asthma (Pharmafile)
  • Gilead’s Kite submits FDA approval application for CAR-T in slow-growing lymphomas (MedCity News)
  • Sanofi's later-stage trials hardest hit by COVID-19: report (Fierce Biotech)
  • Merck chronic cough drug shows mixed results in late-stage clinical trials, raising questions about its future (STAT) (Endpoints)
  • After carefully building up expectations, a small-cap biotech’s big plans come crashing down in PhIII catastrophe (Endpoints)
  • Ahead of merger with Pfizer's generic unit, Mylan makes $757M+ purchase for European thrombosis portfolio (Endpoints)
Medtech
  • Daily Coronavirus Testing at Home? Many Experts Are Skeptical (NYT)
  • ‘An unchartered situation for all of us’: From shipping containers to security concerns, a Covid-19 vaccine supply chain takes shape (STAT)
  • Roche COVID-19, flu combo test gets FDA emergency authorization (MedTech Dive)
  • FDA flags 428 spinal cord stimulator patient deaths, urges more tests before implant (MedTech Dive)
  • Boston Scientific, Stryker win CMS new tech add-on pay, BD left out (MedTech Dive)
  • Roche BK Virus Test Garners FDA Clearance (GenomeWeb)
Government & Regulatory
  • Major COVID-19 Rule Leads Busy Week (American Action Forum)
  • HHS Unit Probes Funding For Moderna's Patented Vaccines (Law360) (STAT)
  • Court Halts Boehringer’s COPD Inhaler Comparative Claims Vs. GSK Products (Pink Sheet)
  • Bold Action Needed to Save Medicare, Says MedPAC Commissioner (MedPage Today)
  • Evidence of 510(k) Clearance Is Relevant and Admissible, Says E.D. Pa. IVC Filter Judge (Drug & Device Law)
  • Why did the US justice department let Purdue off the hook for the opioid crisis? (Guardian)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
 

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